Dental Caries, Gingival Inflammation
Conditions
Keywords
Gingival Index, Plaque Index, Dentifrice, Toothpaste Tablets, Caries Experiences, Consumer Satisfaction
Brief summary
Objectives: To evaluate the effectiveness of toothpaste tablets when compared to conventional dentifrices in removing plaque. Methods: 50 participants are randomized into two groups: Denttabs toothpaste tablets (T) and Colgate's Cavity Protection toothpaste (P). Both groups utilize their assigned dentifrice for 6 weeks. A pre and post-assessment measures the Gingival Index (GI) and Plaque Index (PI) and Decayed, Missing and Filled Teeth (DMFT). A questionnaire on the use of the product is distributed at the end of the study.
Interventions
Denttabs toothpaste tablets
Colgate Cavity Protection toothpaste
Sponsors
Loma Linda University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Subjects are 18 years or older; 2. Subjects who will comply with study protocol; 3. Subjects who can read and understand the consent form; 4. Subjects available during the study period; 5. Subjects have more than 20 teeth.
Exclusion criteria
1\. Subjects under the age of 18.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plaque Index Score at Baseline | Change between baseline at visit 1 and visit 2, six weeks post baseline | The quantity of plaque build-up is measured visually using the Quigley-Hein Plaque Index. The Plaque index can range from 0 to 5, with higher numbers indicating more plaque build-up. |
| Gingival Index Score at Baseline | Change between baseline at visit 1 and visit 2, six weeks post baseline | The severity of gingival inflammation is measured visually using the Loe-Silness Gingival Index. Gingival index can range from 0 to 3, with higher numbers indicating more gingival inflammation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DMFT Score at Baseline | Change between baseline at visit 1 and visit 2, six weeks post baseline | Caries experiences is measured visually using the DMFT index. DMFT score can range from 0 to 28, with higher numbers indicating higher caries experiences. |
| Subject Perception of Product Use | Visit 2 six weeks post study enrollment | The perception on the product usage is measured using a survey containing questions on feel, texture, flavor, ease of use, eco-friendliness, cost and overall satisfaction. Response is on a 4 point Likert scale ranging from strongly agree (1) to strongly disagree (4). |
Countries
United States
Contacts
CONTACTSo Ran Kwon, DDS, MS, PhD
PRINCIPAL_INVESTIGATORSo Ran Kwon, DDS, MS, PhD
Loma Linda University
Outcome results
None listed